W- Can you shortly introduce us Erapharma and yourself?
Ş.D.- ERA Pharma Solutions is a world class R&D and contract analytical services to pharmaceutical industry to provide tailored, innovative solutions to client requirements, founded in 2010. Era Pharma Solutions is the first independent R&D organization dedicated to pharmaceuticals development process in Turkey who includes an internal analysis laboratory and pilot production facility. Our objective is to make contribution to Turkish Health sector fastening the development of the new products and releasing them to the market. We provide the opportunity to develop the Pharmaceuticals having high technological superiority and competition potential to all pharmaceutical companies. We support the domestic production with more modern and higher quality new products.
As to me, I graduated from METU, Faculty of Chemistry and I have worked as an R & D and Regulatory Director and senior manager in pharmaceutical industry for nearly 15 years. Firstly I worked in Abdi İbrahim, Mustafa Nevzat, Frik Pharmaceuticals and finally in Deva Holding as the Vice General Manager Responsible for Technical Operations.
W-What are the services Erapharma provides? How the firms found these services out of their scope previously? Which field has the intensity among your services or are there any fields for which the requests of the firms are intense? What are the net contributions and the advantages you provide for the firms?
Ş.D.- We, as Erapharma, provide services in every field that pharmaceutical companies can encounter from beginning to end of the product development and regulatory processes. Generally, pharmaceutical companies already decide which product to develop when they come to us and demand us to develop it for them. Sometimes we also make contributions in choosing the new product. We perform all the phase of API selection, formulation, analytical validations, pilot production, bioequivalence and regulatory dossier preparation (eCTD) of that new product and provide turn-key service to the firm.
As well as undertaking all the process, we can make some parts for which the firm needs support. Big pharmaceutical companies having R & D activities in their own scope, generally prefer that service; they only get formulation support or they only request us to do the analytical validations for their in-house production. However, the firms not having their own production plants, either importer or companies having toll manufacturing, prefers to perform all the development process with our help from A to Z. Research-based pharmaceutical firms generally request regulatory support and analytical services from us.
We also have requests for the development of cosmetics and food supplement products. But in general the most requested service has been technology transfer in 2011. Since Ministry of Health conditioned GMP audit to all import files and the audits was late , most of the firms came us to get service for technology transfer to start domestic production of these imported products. We are proud of supporting this process which we believe that will give additional contribution to local pharmaceutical industry of our country.
As for this year, we have requests for the new pharmaceutics form and combinational drugs which are more difficult to develop. We believe we achieved that as a result of the faith of the sector in us and our concrete success.
We provide the pharmaceutical firms the opportunity to develop more new products with less investment in a very short time. At the same time, we help them get finance support, reinforcing TÜBİTAK projects of the firm technically.
W- When did you first realize that the sector needs a special R & D centre? Is it a strategic field for Turkey, how can we interpret that?
Ş.D.- As you know, I managed R & D departments in generic drug firms for many years and within that period I wandered professional R & D centres that we encounter many similar samples abroad but unfortunately not existing in Turkey and sometimes we utilized some benefits of them. No matter how big are your R & D team and opportunities, you can’t be expert in every subject and your opportunities are not enough for it. For example, due to the lack of special field you can’t develop the products like oncology products and hormones that require special fields. You need a professional support for the products like controlled release products, combinations, patent article and lyophilized products having complex production technology. At the same time, you don’t want to lose time for the works like Cleaning validation taking so much time and you want to outsource these kind of works but before us there wasn’t any professional R & D centre that can exactly make that job in Turkey and we believe that we broke the new ground in that field.
R & D firms founded for similar objectives were only providing services in main fields. For example, they were giving a service only as CRO and working as a bioequivalence centre or they were founded with the support of a pharmaceutical firm and they were not independent. For that reason, I felt the need of a professional team. We tried to outsource many services in marketing field but outsourcing of R & D is a new field for Turkey yet.
We have no doubt that R & D is a new strategic field for Turkey. The increase of the R & D supports of the government in recent years is also the indication of that. The policy of reduction of the import drugs and the encouragement of the domestic production increased the importance of R & D still more.
W- Are there any requests from abroad for your services?
Ş.D.- Yes, we also receive request of technology transfer from abroad. Foreign firms trying to enter Turkey recently also request the regulatory support.
W- The structure of Turkish pharmaceutical sector has been changing both on the basis of volume and sum. In parallel with that can we learn your future predictions and the preparations devoted to it?
Ş.D.- Cost issue has acquired a very serious dimension with the price reductions in recent years. In my opinion, excessive fragmentation in generic drug field in Turkey will decrease. The more the competition environment appears, the more the demand for the innovative products increases. The products produces with more modern technology and bigger capacity will be compulsory to produce the products cheaper. Generic industry will tend to the products whose profit margin is higher and which is more expensive.
We are ready to give all kinds of support to pharmaceutical firms in this field. We are trying to support the firms with many alternative cost reduction opportunities such as creating alternative raw material variation, reviewing the production process and decreasing the factors creating cost to minimum, making stability research. Moreover, we make contribution to expand the product range and to decrease the total cost developing the new pharmaceutical forms of the present productions.
Moreover, transfer from traditional products to the products and areas that require advanced technology (such as Biotechnology) is becoming fast day by day. Firms which are late for making investment in those fields now will be excluded from the competition in the close near future.
W-How the constitution of Turkish Drug and Medical Device Institution affected you?
Ş.D.-As a person who supports and looks forward to the constitution of it, I personally believe that this will have very positive effects. We are talking about an institution having wider authorities with more central structure implementing FDA model. It is normal to have some troubles due to the appointments in some departments and the personnel changes in transition period, but I believe that it will be much more competent and independent institution that can create more sound strategies in the long term .
I want to remind that it has led to many huge projects leading revolutionary changes in our pharmaceutical industry realized by General Directorate for Pharmaceuticals and Pharmacy and it completed these processes successfully; European regulations harmonization studies, Transition to CTD, Transition from Prospectus to Package Insert, Data Matrix application, e-CTD and on-line application process are only some of these.
W-There are criticisms about drug regulatory, especially about timing-process in Turkey? Is there any points you have to advance in regulatory regulation? Is it possible to differentiate as prescription and non-prescription? Besides is there any preparation or service you provide about OTC?
Ş.D.-Regulatory process results in much more properly with the applications I mentioned when compared with the past. However, there are still some bottlenecks. There are many issues which exist in European regulations but still not applied seriously in our country like line-extension, orphan drug application and bibliographic application. Although there are improvements in sanitation analysis which takes the biggest time in Regulatory process formerly, it is the subject we still have to advance.
As you know, Intermediate Product regulation was abolished and “Non-Prescription Product” document has been enabled to pass but OTC act is still not issued. We hope it will be issued in a short time to put an end to the complication about that subject. “Traditional Herbal Medicinal Products” directive for Food Supplements has been issued but unfortunately a very comprehensive CTD file is requested for herbal product and for this reason it couldn’t lead the firms prefer the approval of the Ministry of Health instead of the approval of the Ministry of Agriculture for these kinds of products of the firms as expected. Many firms prefer the approval of the Ministry of Agriculture since it is quicker and easier.
We also provide service in that issue and we can develop “Traditional Herbal Medicinal Product” and prepare the regulatory file.
W-While providing these services to the firms, actually you become both a strategic solution partner and a very important confidant. What are your standards-applications related to that issue?
Ş.D.-Generally we work dependant on exclusivity system. In other words, we don’t develop the products for a firm which we developed for the other firm. Moreover, we have taken very serious precautions devoted to enabling the data safety and privacy policy. Apart from our privacy contracts covering all our personnel, we apply special coding system for each new project. Thus, the project, product name and sponsorship name is strongly kept confidential. Product, customer name and related parts on each coming sample are covered with a special label. In this way, it is prevented that analysts and visitors learn the product information during the researches. Manual records belonging to the products are done with a special coding. All the digital records are recorded regularly to the server system having limited user log-in and programmed specially. Hard copy records are kept in the archives which can only be reached by the director.
W-What are the standards and the documents you have as an R & D centre? R & D studies of a drug, which will be released to the consumption in Turkey, can be performed in abroad. How the Ministry controls this?
Ş.D.- We are an accredited laboratory in drug analysis. We have 17025 laboratory accreditation documents and we were inspected from an abroad centre for GLP document. Many local and foreign firms working with us have inspected us with their own quality assurance teams and found our researches suitable as required by their internal standards.
Since there is no R & D regulation in our country yet and the concepts like GLP are only handled as a subheading of GMP, unfortunately the Ministry doesn’t have an opportunity to inspect the R & D studies performed in abroad. There is serious lack of regulation related to this issue.
W-There will be a classical question, do you think innovation in pharmaceutics in Turkey possible? What are the contributions you can make in that issue?
Ş.D.-It depends on what you intend from innovation. New molecule exploration has been decreased in the last 50 years all over the world and our chance in that issue is less. Since such a big investment to R & D and long waiting period is very luxury for us yet. However, in my opinion innovation shouldn’t be only limited with molecule exploration. Finding of a new indication, new combination and reduction of adverse effects, creating a new pharmaceutical form are definitely innovation. I think that we are very successful in this field. However, in order to advance more, it should become a government policy and be supported in all fields.
W- Should domestic industry tend to modifications or combinations instead of innovation? How can Erapharma give support in that issue?
Ş.D.- I think I responded it in the previous question.
W- Do you think what are the important developments which can affect Turkish Pharmaceutical sector? Do you think what should be the priorities of Turkish Pharmaceutical Sector? Is there any country that Turkish Pharmaceutical Industry can take as a model? Can we receive a road map suggestion for the development?
Ş.D.-There are many factors that affect pharmaceutical industry all over the world. In a global environment, the borders are blurring more and more. We are in a period in which mergers and purchasing are inevitable. Original pharmaceutical sector also comprehended the importance of generic pharmaceutics and all big original firms have a generic branch now. The reductions in pharmaceutics prices and the limitations in repayment system are not only special to our country and they continue with similar speed all over the world. We are living in a period that electronic media advertising changes the marketing models. For that reason, according to me, firms that have more technological products with lower costs and make use of the technology more will get ahead in the competition. There is not an exact model we take as an example but I think India can be a good example we should follow.
W- Pharmaceutics is a strategic sector in the world. Is Turkey aware of that or do we have a luxury to ignore it? While hi-tech products and biotechnological products gain importance in the world, where do we stand related to that issue?
Ş.D.-I think consciousness about that issue is increasing day by day. The stimulus package issued lastly is the indication of this but I don’t believe it is in a sufficient level. We are in the first 15 in pharmaceutical sector all over the world but we are candidate to enter first 10 and it is very difficult to catch it in other sectors. In order to take this development further, the increase of the government support and convenience for the related regulations are needed. There are many developments in biotechnology field but they are not sufficient yet and need to be supported.
W-Anything you want to add…
Thanks for your interest, we wish you continue your successful studies.
